ADCETRIS (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC)
consisting of three components: 1) the chimeric IgG1 antibody cAC10, specific
for human CD30, 2) the microtubule disrupting agent MMAE, and 3) a protease-cleavable
linker that covalently attaches MMAE to cAC10.
Brentuximab vedotin has an approximate molecular weight of 153 kDa. Approximately
4 molecules of eachMMAE are attached to antibody molecule. Brentuximab vedotin
is produced by chemical conjugation of the antibody and small molecule components.
The antibody is produced by mammalian (Chinese hamster ovary) cells, and the
small molecule components are produced by chemical synthesis.
ADCETRIS (brentuximab vedotin) for Injection is supplied as a sterile, white
to off-white, preservative-free lyophilized cake or powder in single-use vials.
Following reconstitution with 10.5 mL Sterile Water for Injection, USP, a solution
containing 5 mg/mL brentuximab vedotin is produced. The reconstituted product
contains 70 mg/mL trehalose dihydrate, 5.6 mg/mL sodium citrate dihydrate, 0.21
mg/mL citric acid monohydrate, and 0.20 mg/mL polysorbate 80 and water for injection.
The pH is approximately 6.6.
Last reviewed on RxList: 1/24/2012
This monograph has been modified to include the generic and brand name in many instances.